Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

GEI 2022-10-16

LUDWIG Electrosurgical Device

Applicant Aesthetics Biomedical

K-Number K221574

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DQA 2022-10-16

Pulse Oximeter (Model C101A2, C101B1, C101A3)

Applicant Shenzhen Imdk Medical Technology Co., Ltd.

K-Number K221979

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BXN 2022-10-16

STIMPOD NMS450 Nerve Stimulator

Applicant Xavant Technology (Pty), Ltd.

K-Number K213049

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ODP 2022-10-15

CONDUIT Cages; FIBERGRAFT BG Putty

Applicant Depuy Spine

K-Number K222276

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NGX 2022-10-14

CoreLevee

Applicant Lutronic Corporation

K-Number K213748

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IPF 2022-10-14

Shoulder PacemakerTM

Applicant Ncs Lab Srl

K-Number K220994

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DQY 2022-10-14

Sublime Microcatheter

Applicant Surmodics,Inc.

K-Number K221886

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OHT 2022-10-14

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

Applicant Shenzhen Ishine Technology Company Limited

K-Number K222537

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MAX 2022-10-14

ZSFab Lumbar Interbody System

Applicant Zsfab, Inc.

K-Number K221858

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LLZ 2022-10-14

syngo.via View&GO

Applicant Siemens Healthcare GmbH

K-Number K221501

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GEI 2022-10-14

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

Applicant Applied Medical Resources Corporation

K-Number K222284

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DYH 2022-10-14

TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520

Applicant Tp Orthodontics, Inc.

K-Number K214054

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